Evoke Pharma top-line results with EVK-001 miss primary endpoint

Shares of Evoke Pharma (Nasdaq: EVOK) plunged 72.5% to $2.95 in heavy afternoon trading on Monday, after the company announced disappointing top-line results from its Phase III clinical trial of EVK-001 in female patients with symptomatic diabetic gastroparesis.

In this study, EVK-001, the company's patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women, did not achieve its primary endpoint of symptom improvement at Week 4.

Preliminary review of top-line data across all study sites revealed similar improvement in the EVK-001 and placebo groups at Week 4 as measured by the total symptom score as well as the individual scores for each of the signs and symptoms, but these results were not consistent across the study sites. Further evaluation of top-line data revealed diary data from 28 of 41 of the enrolling sites showed a statistically-significant benefit at Week 4 for EVK‑001 (p=0.006) in contrast to results from the other 13 sites that showed statistically significant benefit for placebo (p=0.002). Once the complete datasets and PK data are available, additional analyses will be conducted to further understand the discrepant results.